IMUNON Announces Results from its End-of-Phase 2 Meeting with the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer
IMUNON (NASDAQ: IMNN) announced successful results from its End-of-Phase 2 meeting with the FDA for IMNN-001, its DNA-mediated immunotherapy for advanced ovarian cancer. The FDA supported the company's proposed Phase 3 trial strategy, including trial design, patient population, and endpoints. The 500-patient Phase 3 trial is scheduled to begin in Q1 2025. The company's Phase 2 OVATION 2 Study showed approximately one-year (35%) improvement in overall survival when IMNN-001 was combined with standard chemotherapy compared to chemotherapy alone. The treatment demonstrated good tolerability with no serious immune-related adverse events.
IMUNON (NASDAQ: IMNN) ha annunciato risultati positivi dal suo incontro di fine fase 2 con la FDA per IMNN-001, la sua immunoterapia a base di DNA per il cancro ovarico avanzato. La FDA ha sostenuto la strategia proposta dall'azienda per il trial di fase 3, compresi il design dello studio, la popolazione di pazienti e gli obiettivi. Il trial di fase 3, che coinvolgerà 500 pazienti, è previsto per iniziare nel primo trimestre del 2025. Lo studio di fase 2 OVATION 2 dell'azienda ha mostrato un miglioramento di circa un anno (35%) nella sopravvivenza globale quando IMNN-001 è stato combinato con la chemioterapia standard, rispetto alla sola chemioterapia. Il trattamento ha dimostrato una buona tollerabilità senza eventi avversi gravi correlati al sistema immunitario.
IMUNON (NASDAQ: IMNN) anunció resultados exitosos de su reunión de fin de fase 2 con la FDA para IMNN-001, su inmunoterapia mediada por ADN para cáncer de ovario avanzado. La FDA apoyó la estrategia propuesta por la compañía para el ensayo de fase 3, incluyendo el diseño del ensayo, la población de pacientes y los puntos finales. Se espera que el ensayo de fase 3, que contará con 500 pacientes, comience en el primer trimestre de 2025. El estudio de fase 2 OVATION 2 de la compañía mostró una mejora de aproximadamente un año (35%) en la supervivencia general cuando IMNN-001 se combinó con la quimioterapia estándar, en comparación con la quimioterapia sola. El tratamiento demostró buena tolerabilidad sin eventos adversos graves relacionados con el sistema inmunológico.
IMUNON (NASDAQ: IMNN)은 고급 난소암에 대한 DNA 기반 면역 요법인 IMNN-001에 대해 FDA와의 2상 종료 미팅에서 성공적인 결과를 발표했습니다. FDA는 시험 설계, 환자 집단 및 목표를 포함한 회사의 3상 시험 전략을 지지했습니다. 500명의 환자를 대상으로 한 3상 시험은 2025년 1분기에 시작될 예정입니다. 회사의 2상 OVATION 2 연구는 IMNN-001이 표준 화학요법과 결합되었을 때 단독 화학요법에 비해 전체 생존율이 약 1년 (35%) 개선되었다는 결과를 보였습니다. 치료는 면역 관련 중대한 부작용 없이 좋은 내약성을 보였습니다.
IMUNON (NASDAQ: IMNN) a annoncé des résultats positifs de sa réunion de fin de phase 2 avec la FDA concernant IMNN-001, son immunothérapie à base d'ADN pour le cancer de l'ovaire avancé. La FDA a soutenu la stratégie proposée par l'entreprise pour l'essai de phase 3, y compris la conception de l'essai, la population de patients et les critères d'évaluation. L'essai de phase 3, qui impliquera 500 patients, devrait commencer au premier trimestre 2025. L'étude de phase 2 OVATION 2 de l'entreprise a montré une amélioration d'environ un an (35%) de la survie globale lorsque IMNN-001 était associé à la chimiothérapie standard, par rapport à la chimiothérapie seule. Le traitement a montré une bonne tolérance sans événements indésirables graves liés à l'immunité.
IMUNON (NASDAQ: IMNN) gab erfolgreiche Ergebnisse aus seinem Abschlussgespräch zur Phase 2 mit der FDA für IMNN-001, seine DNA-vermittelte Immuntherapie gegen fortgeschrittenen Ovarialkrebs, bekannt. Die FDA unterstützte die von dem Unternehmen vorgeschlagene Strategie für die Phase 3-Studie, einschließlich Studienaufbau, Patientenauswahl und Endpunkte. Die 500-Patienten umfassende Phase 3-Studie soll im ersten Quartal 2025 beginnen. Die Phase 2-Studie OVATION 2 des Unternehmens zeigte eine Verbesserung von etwa einem Jahr (35%) in der Gesamtüberlebensrate, als IMNN-001 mit der Standardchemotherapie kombiniert wurde, im Vergleich zur alleinigen Chemotherapie. Die Behandlung zeigte eine gute Verträglichkeit ohne schwerwiegende immunbedingte Nebenwirkungen.
- FDA supports advancement to Phase 3 trial
- Phase 2 study showed 35% improvement in overall survival
- Treatment demonstrated good safety profile with no serious immune-related adverse events
- First immunotherapy to achieve clinically effective response in ovarian cancer
- None.
Insights
The FDA's support for IMUNON's Phase 3 trial design for IMNN-001 in advanced ovarian cancer represents a significant milestone. The Phase 2 OVATION 2 Study demonstrated remarkable results with a
The planned 500-patient Phase 3 trial could be transformative for ovarian cancer treatment. The safety profile is encouraging, with no cytokine release syndrome or serious immune-related adverse events reported. The intraperitoneal administration of IL-12 immunotherapy represents an innovative approach to treating this challenging disease. However, investors should note that Phase 3 success is not guaranteed and the trial's initiation in Q1 2025 means significant time before potential commercialization.
For a micro-cap company with a market cap of
The company's focus on advanced ovarian cancer, which has effective treatment options, presents a significant market opportunity. If successful, IMNN-001 could capture meaningful market share as the first effective immunotherapy in this indication. Investors should monitor the company's cash position and financing strategy leading up to the Q1 2025 trial initiation.
FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint
Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025
LAWRENCEVILLE, N.J., Nov. 25, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the outcome of its recent End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of its investigational interleukin-12 (IL-12) immunotherapy IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. IMUNON remains on track to initiate the 500-patient Phase 3 trial in the first quarter of 2025.
“The collaborative End-of-Phase 2 meeting with the FDA represents another important milestone in our IMNN-001 clinical program, and we are very pleased that the Agency is aligned with the potential for IMNN-001 to address a significant unmet need in ovarian cancer treatment and our Phase 3 plans,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “We are encouraged by the robust safety and efficacy data from our Phase 2 OVATION 2 Study, including the positive survival results recently presented in a late-breaking session at the SITC Annual Meeting. IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment.”
“Our goal is to replicate these remarkable results in a Phase 3 trial, which would be transformative for the current standard of care, substantially improving overall survival and giving hope to thousands of women with advanced ovarian cancer who continue to experience disease progression,” Dr. Lindborg added.
The interaction with the FDA included an extensive review of data generated to date, including positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. The OVATION 2 Study results demonstrated that IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in approximately a one-year (
About IMNN-001 Immunotherapy
Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.
About Epithelial Ovarian Cancer
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately
About IMUNON
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). IMUNON will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure of conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
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FAQ
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